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romidepsin

Generic: ROMIDEPSIN·Brand: ISTODAX, Istodax, ROMIDEPSIN

romidepsin: sourced relationships with 1 company · 1 clinical trial tracked · 1 FDA decision.

romidepsin evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect romidepsin to BMY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could romidepsin → BMY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
BRISTOL MYERS SQUIBB CO (BMY)
Reported 2009-11-05 · Current development: unknownSource
Approved
Clinical Trial Registry Records (1)

HERO Trial: Phase I Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents in Localized Bladder Cancer

NCT06963346Registry updated 2026-07-30·Phase 1
Recruiting

Primary endpoint: Romidepsin Maximum Tolerated Dose (MTD)

Interventionalopen12 targetStarted 2025-06Completion 2028-041 site · United StatesH. Lee Moffitt Cancer Center and Research Institute
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).(BMY)FDA ↗
NDA022393Type 1 - New Molecular EntityOrphan DrugStandardIntravenousPowder

Frequently asked questions

Which companies have sourced relationships with romidepsin?

romidepsin has dated SEC/FDA relationship records for BRISTOL MYERS SQUIBB CO.

How many clinical trials involve romidepsin?

BioSniper tracks 1 clinical trial involving romidepsin.

What is romidepsin's latest FDA decision?

The most recent tracked FDA decision for romidepsin is Approval for 1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 )., dated November 5, 2009.